Search Results

Rio™ Vial-to-Bag Drug Reconstitution Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

Rio™ Vial-to-Bag Drug Reconstitution Device (Rio™) is a single use, sterile, two-way, drug transfer device that is designed and indicated to connect an ICU Medical LifeCare IV container system (IV bag)(up to 250 mL) via the drug additive port, to a drug vial having a 20mm stopper closure for reconstituting or mixing and aseptic transfer of the drug from the vial into the solution of the IV bag. Once connected, Rio™ is not separated from the IV bag or vial, and should be disposed of with the IV bag when administration is complete. Rio™ is intended to be used in a pharmacy setting or patient care area, by trained clinicians. RioTM design consists of a port spike that connects to the compatible IV bag on one end, and a vial spike on the other end to connect a standard liquid or lyophilized/powdered drug vial having a 20mm closure. The bag spike and vial spike contain protective caps that maintain the sterility of the device until the caps are removed prior to use. Rio™ also includes a flow director (rotating handle) that will isolate the fluid between the vial and bag until manipulated by the pharmacist or clinician to allow two-way fluid transfer between the vial and bag. Rio™ is needlefree and will passively aid in the prevention of needlestick injuries.

The provided document is a 510(k) summary for the Rio™ Vial-to-Bag Drug Reconstitution Device. It describes the device, its intended use, and compares it to a predicate device. It also mentions non-clinical testing performed to support its safety and effectiveness.

However, the document does not contain specific acceptance criteria values or detailed results of a study proving the device meets those criteria in a format that would allow for the construction of the requested table. Specifically, it lacks:

• Specific quantitative acceptance criteria: The document lists types of tests (e.g., Positive pressure leak, Fluid flow, Particulate testing) but does not provide numerical thresholds or pass/fail definitions for these tests.
• Reported device performance data: While it states "the new device met its design specifications and performs as intended," it does not provide the actual measured performance values from the tests.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement, which are typically associated with studies involving AI or complex diagnostic systems, and are not relevant to this type of mechanical medical device submission which focuses on functional and material testing.

Therefore, I cannot generate the requested table and detailed study information based on the provided text. The submission focuses on demonstrating substantial equivalence through comparison to a predicate device and extensive physical and material testing, rather than a clinical effectiveness study with human readers or AI.

Here's a breakdown of why the requested elements cannot be fulfilled from the provided text:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated with quantitative values. The document mentions functional performance per ISO standards (e.g., ISO 8536-4, ISO 22413), particulate testing per ISO 8536-4 and USP, biocompatibility per ISO 10993-1, sterilization per ISO 11137, and packaging per ISO 11607. These standards contain acceptance criteria, but the specific criteria applied (e.g., maximum leakage rate, particle count limits) are not detailed in this summary.
   • Reported Device Performance: The document only makes a general statement that "the new device met its design specifications and performs as intended." No specific performance metrics or values are reported.

2. Sample size used for the test set and the data provenance: Not mentioned. This type of detail is typically included in full test reports, not a 510(k) summary. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device and testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a mechanical drug reconstitution device, not an interpretative diagnostic device requiring expert ground truth establishment.

4. Adjudication method for the test set: Not applicable for this type of device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's testing would be defined by the specifications and performance requirements of the relevant ISO and USP standards for mechanical and material properties.

8. The sample size for the training set: Not applicable. This device does not use machine learning or AI that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device